Description

RESVAC® BRSV/SOMUBAC® consists of a standardized, freeze-dried, attenuated strain of BRSV propagated in a stable cell line; accompanied by liquid, inactivated, standardized Haemophilus somnus bacterin diluent. Somubac® is prepared from selected strains of Haemophilus somnus which are grown serum-free in an environmentally controlled fermentation system and inactivated in such a manner as to maintain their immunogenic integrity. The bacterin is adjuvanted with aluminum hydroxide. The vaccine virus is produced under the precisely controlled conditions of Zoetis Inc.’s Frozen Stable Cell Bank™ system. The use of this special cell system in producing Resvac® BRSV ensures freedom from potentially harmful adventitious agents. The vaccine virus is blended with a special stabilizer and presented in freeze-dried form. The product is tested for purity, safety, potency, and efficacy in accordance with the regulations of the United States Department of Agriculture.

Contains polymyxin B and neomycin as preservatives.

Resvac BRSV/Somubac Indications

RESVAC® BRSV/SOMUBAC® is for vaccination of healthy cattle as an aid in preventing disease caused by bovine respiratory syncytial virus (BRSV) and Haemophilus somnus.

Directions For Use

1. General Directions: Vaccination of healthy cattle is recommended. Aseptically rehydrate the freeze-dried vaccine with the liquid bacterin provided, shake well, and administer 2 mL intramuscularly. In accordance with Beef Quality Assurance guidelines, this product should be administered in the muscular region of the neck.

2. Primary Vaccination: Administer a single 2-mL dose to healthy cattle 3 months of age or older, followed by a second dose 2-4 weeks later.

3. Revaccination: Annual revaccination with a single dose is recommended. Calves with maternal antibodies may not develop or maintain satisfactory levels of immunity; therefore, calves vaccinated before 6 months of age should be revaccinated at 6 months of age or at weaning.

4. Good animal husbandry and herd health management practices should be employed.

Sterilized syringes and needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of disinfectant may inactivate the vaccine.

Burn containers and all unused contents.

Caution(s): Safety of this vaccine for use in pregnant cattle has not been established.

As with many vaccines, anaphylaxis may occur after use. Initial antidote of epinephrine is recommended and should be followed with appropriate supportive therapy.

This product has been shown to be efficacious in healthy animals. A protective immune response may not be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not administered in accordance with label directions.

Warning(s): Do not vaccinate within 21 days before slaughter.

For veterinary use only.

Discussion: Disease Description: Laboratory diagnosis of BRSV has proven difficult, and only recently has it gained recognition as an important component of the bovine respiratory disease complex. As a causative agent, the virus is a pathogen of the lower respiratory tract with characteristic clinical signs of serous nasal discharge, coughing, lacrimation, and pyrexia. Subclinical infections can occur and have been shown to predispose cattle to secondary bacterial infections. Based on antibody prevalence, approximately 2/3 of all herds, both beef and dairy, have been exposed. Exacerbation of clinical signs has been documented when concurrent BRSV and BVD or IBR infection exists.

Diseases associated with Haemophilus somnus are widespread and occur sporadically in beef and dairy cattle populations. Several disease manifestations are observed. In the respiratory form, the infected animal develops an acute fibrinous pneumonia and pleuritis. The disease may become septicemic, with the involvement of most tissues and organs. A temperature response from 106°-108°F is common. If death does not occur, the animal becomes a poor weight gainer, and may develop other signs such as arthritis, knuckling, and a dry, hacking cough.

Another disease manifestation resulting from septicemia is infectious thromboembolic meningoencephalitis (TEME), which can occur without any obvious respiratory involvement. The septicemia may lead to vasculitis and thrombosis, and disease can be expressed in several syndromes. Many times the first sign of the disease is finding dead cattle. Early signs are stiffness, listlessness, and high temperatures. Circling may occur with abnormal eye movements, along with muscular tremors due to CNS involvement. Death occurs in a few hours in acute cases.

Haemophilus somnus has also been incriminated in reproductive disorders of beef and dairy cattle.

Trial Data: Purity - The master seed virus was purified using the latest available procedures to assure the highest degree of purity. The master cell stock was prepared and pretested for use in vaccine production. The master cell stock and master seed virus were found to be negative for bacteria, fungi, mycoplasma, and adventitious viruses.

Safety and Efficacy: Studies in cattle show RESVAC® BRSV/SOMUBAC® to be safe and free from untoward reactions. This product was field tested in hundreds of cattle by practicing veterinarians. No undesirable effects attributable to the product were noted. Vaccination/challenge studies in cattle showed Resvac® BRSV to be effective as an aid in the prevention of disease caused BRSV. Cattle vaccinated with Somubac® were protected against challenge with a highly virulent strain of Haemophilus somnus. Antigen interference studies in cattle show each fraction of the RESVAC® BRSV/SOMUBAC® combination to be compatible.

75-4314-05

Presentation: 1 x 10 dose or 1 x 50 dose vials with diluent.

NAC No.: 36900212

ZOETIS INC.333 PORTAGE STREET, KALAMAZOO, MI, 49007

Telephone:

269-833-4000

Customer Service:

888-963-8471

Website:

www.zoetis.com

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